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FDA feedback clears path for NSB’s StemSmart Crohn’s trial
9:31am on Tuesday 13th of October, 2026 AEDT
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Biotechnology
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FDA feedback clears path for NSB’s StemSmart Crohn’s trial
9:31am on Tuesday 13th of October, 2026 AEDT
Key Points
FDA supports proposed Phase 2 trial design
Existing human data package accepted without further non-clinical studies
StemSmart release-testing strategy receives regulatory support
Viral contamination controls remain outstanding in manufacturing
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